Celgene’s Revlimid Approved for Expanded Combo Use

FDA has approved a Celgene supplemental NDA for Revlimid (lenalidomide) in combination with rituximab for treating adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma. The company says that this is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma that does not include chemotherapy.

Approval is based primarily on results from the Phase 3 AUGMENT study, which evaluated the combination’s efficacy and safety versus rituximab plus placebo in patients with previously treated FL. The study demonstrated that the combination had a statistically significant improvement in the primary endpoint of progression-free survival versus the rituximab-placebo. The median progression-free survival was 39.4 months for the combination-treated patients and 14.1 months for those treated with rituximab and placebo, the company says.